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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

General Anesthesia versus Local Anesthesia in StereotaXY (GALAXY) for Parkinson’s disease: study protocol for a randomized controlled trial

Authors: R. A. Holewijn, D. Verbaan, R. M. A. de Bie, P. R. Schuurman

Published in: Trials | Issue 1/2017

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Abstract

Background

The aim of the study is to investigate if deep brain stimulation (DBS) in the subthalamic nucleus (STN) for Parkinson’s disease (PD) under general anesthesia further improves outcome by lessening postoperative cognitive, mood, and behavioral adverse effects; shorten surgical time and hospital admittance; and produce comparable symptomatic and functional improvement to surgery under local anesthesia.

Methods/design

The study will be a single-center, prospective, randomized, open-label, blinded endpoint trial comparing DBS under general anesthesia with DBS under local anesthesia. The primary outcome measure is a composite score of the postoperative cognitive, mood, and behavioral adverse effects and will be measured 6 months after surgery. The secondary outcome measures consist of changes in motor symptoms, adverse effects of stimulation and surgical complications, surgical time, functional health, quality of life, patient satisfaction with the outcome of treatment, patient evaluation of the burden of therapy, and medication. A total of 110 patients with advanced PD who are candidates for DBS will be randomized during a 2.5-year period.

Discussion

The aim of this trial is to further enhance the effectiveness of DBS treatment in PD while reducing the burden of DBS surgery by studying if DBS surgery under general anesthesia results in less cognitive, mood, and behavioral adverse effects compared with surgery under local anesthesia.

Trial registration

Netherlands Trial Register, NTR5809. Registered on 23 April 2016.
Appendix
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Metadata
Title
General Anesthesia versus Local Anesthesia in StereotaXY (GALAXY) for Parkinson’s disease: study protocol for a randomized controlled trial
Authors
R. A. Holewijn
D. Verbaan
R. M. A. de Bie
P. R. Schuurman
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2136-8

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